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Technology Assisted Programs That Promote Mental Health for Teenagers (ProjectTECH)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Networked Peer Support with Peer Guide
Networked Peer Support with Clinician Coach
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Depression prevention, Technology Assisted, Adolescents, Peer networked

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Has a score of 12-39 (males) / 15-39 (females) on the Center for Epidemiologic Studies Depression Scale (CES-D) OR reported past month use of marijuana, cigarettes, alcohol or other substances on the Center for Disease Control Youth Risk Behavior Survey (YRBS).
  • Is familiar with the use of computers and the Internet, as well as mobile phones
  • Is able to speak and read English
  • Is between 14-19 years of age

Exclusion Criteria:

  • Is currently taking an antidepressant medication or has taken one in the previous 3 months
  • Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the Internet or mobile phone
  • Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance dependence, or other diagnosis for which participation in this trial is either inappropriate or dangerous. Inclusion of participants with symptoms of anxiety disorders, eating disorders and substance abuse disorders will be made on a case-by-case basis.
  • Is severely suicidal (has ideation, plan, and intent in the past 12 months) .

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Networked Peer Support with Peer Guide

Networked Peer Support with Clinician Coach

Wait List Control

Arm Description

Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.

Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.

Participants may be asked to wait for up to 8 weeks until minimum group size is met. After 4 weeks from baseline, if a group has not yet started, we will conduct another assessment. These participants will serve as the Wait List Control group.

Outcomes

Primary Outcome Measures

Program Logins Per Participant by Week.
Program usage data were examined by number of logins per participant by week. Participants in the study tended to access the program multiple times and explored the program tools.
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
A modified version of the Usefulness, Satisfaction and Ease of use questionnaire (USE; Lund, 2001) was used, particularly regarding the participants' relationships with the peer network. The USE questionnaire is a 19 item measure of usability with 4 subscales: Usefulness, Ease of Learning, Ease of Use, and Satisfaction. The items are rated on 7 point Likert rating scales, with 1 = Strongly disagree to 7 = Strongly agree. Lund, A.M., 2001. Measuring Usability with the USE Questionnaire.
SUS (System Usability Scale) Questionnaire
The SUS questionnaire is a 10 item measure that assesses usability, acceptability and satisfaction; each item has five response options for respondents, from 1 = Strongly disagree to 5 = Strongly agree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Specifically, for odd items: subtract one from the user response. For even-numbered items: subtract the user responses from 5. This scales all values from 0 to 4 (with four being the most positive response). Add up the converted responses for each user and multiply that total by 2.5. This converts the range of possible values from 0 to 100 instead of from 0 to 40. A SUS score above a 68 would be considered above average and anything below 68 is below average.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2013
Last Updated
November 20, 2018
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01912729
Brief Title
Technology Assisted Programs That Promote Mental Health for Teenagers
Acronym
ProjectTECH
Official Title
Technology Assisted Intervention for the Treatment and Prevention of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The mission of this project is to develop novel systems of care that can provide efficacious, scalable, cost-effective, participant friendly behavioral intervention technologies (BITs) for the prevention of depression in adolescents. The investigators define BITs as interventions that use information and telecommunications technologies such as the internet, mobile or traditional phones, computers and/or other technologies to support and deliver psychological and behavioral interventions. Through usability testing, focus interviews, and field trials, investigators may modify the technologies and intervention based on immediate usage data.
Detailed Description
The mission of this project is to develop novel systems of care that can provide efficacious, scalable, cost-effective, participant friendly behavioral intervention technologies (BITs) for the prevention of depression in adolescents. The investigators define BITs as interventions that use information and telecommunications technologies such as the internet, mobile or traditional phones, computers and/or other technologies to support and deliver psychological and behavioral interventions. Through usability testing, focus interviews, and field trials, investigators may modify the technologies and intervention based on immediate usage data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression prevention, Technology Assisted, Adolescents, Peer networked

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Networked Peer Support with Peer Guide
Arm Type
Experimental
Arm Description
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a trained peer coach.
Arm Title
Networked Peer Support with Clinician Coach
Arm Type
Experimental
Arm Description
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a mobile phone application. Additionally, participants will have access to a private social network that connects them with other participants in the study. The social network will be moderated by a clinician coach.
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Participants may be asked to wait for up to 8 weeks until minimum group size is met. After 4 weeks from baseline, if a group has not yet started, we will conduct another assessment. These participants will serve as the Wait List Control group.
Intervention Type
Behavioral
Intervention Name(s)
Networked Peer Support with Peer Guide
Intervention Description
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants.
Intervention Type
Behavioral
Intervention Name(s)
Networked Peer Support with Clinician Coach
Intervention Description
Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist.
Primary Outcome Measure Information:
Title
Program Logins Per Participant by Week.
Description
Program usage data were examined by number of logins per participant by week. Participants in the study tended to access the program multiple times and explored the program tools.
Time Frame
Weeks 1-8
Title
USE (Usefulness, Satisfaction and Ease of Use) Questionnaire
Description
A modified version of the Usefulness, Satisfaction and Ease of use questionnaire (USE; Lund, 2001) was used, particularly regarding the participants' relationships with the peer network. The USE questionnaire is a 19 item measure of usability with 4 subscales: Usefulness, Ease of Learning, Ease of Use, and Satisfaction. The items are rated on 7 point Likert rating scales, with 1 = Strongly disagree to 7 = Strongly agree. Lund, A.M., 2001. Measuring Usability with the USE Questionnaire.
Time Frame
Week 4 and Week 8
Title
SUS (System Usability Scale) Questionnaire
Description
The SUS questionnaire is a 10 item measure that assesses usability, acceptability and satisfaction; each item has five response options for respondents, from 1 = Strongly disagree to 5 = Strongly agree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Specifically, for odd items: subtract one from the user response. For even-numbered items: subtract the user responses from 5. This scales all values from 0 to 4 (with four being the most positive response). Add up the converted responses for each user and multiply that total by 2.5. This converts the range of possible values from 0 to 100 instead of from 0 to 40. A SUS score above a 68 would be considered above average and anything below 68 is below average.
Time Frame
Week 4 and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Has a score of 12-39 (males) / 15-39 (females) on the Center for Epidemiologic Studies Depression Scale (CES-D) OR reported past month use of marijuana, cigarettes, alcohol or other substances on the Center for Disease Control Youth Risk Behavior Survey (YRBS). Is familiar with the use of computers and the Internet, as well as mobile phones Is able to speak and read English Is between 14-19 years of age Exclusion Criteria: Is currently taking an antidepressant medication or has taken one in the previous 3 months Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the Internet or mobile phone Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance dependence, or other diagnosis for which participation in this trial is either inappropriate or dangerous. Inclusion of participants with symptoms of anxiety disorders, eating disorders and substance abuse disorders will be made on a case-by-case basis. Is severely suicidal (has ideation, plan, and intent in the past 12 months) .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Mohr, Ph.D
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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